Calcinosis cutis in SSc patients treated with sodium thiosulfate assessed by biomarkers and imaging
- Conditions
- Calcinosis cutis in systemic sclerosisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-510255-34-00
- Lead Sponsor
- Aarhus Universitetshospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
SSc fulfilling ACA/EULAR 2013 criteria as well as patients with positive U1RNP and mixed connective tissue disease with overlap syndrome to SSc, Provides signed, written informed consent, Above 18 and under 90 years of age at baseline, Legally competent, able to give verbal, written and informed consent, Communicate in Danish verbally as well as in writing, Subject in good general health and willing to participate, Is willing and able to comply with the requirements of the protocol and to undergo all testing, Medications for SSc are stable for at least 6 weeks prior to study entry, If subjects received STS treatment on the selected lesion before, a washout period of 3 months must be complete upon study entry
Individuals with other skin diseases in the skin area of interest, Individuals with CC of other causality, Individuals whose CC lesion is not accessible for imaging e.g., inside the ear, inside nostrils., Pregnancy, Breastfeeding, Women of child-bearing potential not using a contraceptive agent at the time of inclusion, Known hypersensitivity to STS
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method